# FDA 483 - Turncare, Inc - June 26, 2023

Source: https://www.keypedia.com/records/483/turncare-inc/85ac333f-291e-45fc-bcb1-58a358e74b0d

> FDA 483 for Turncare, Inc on June 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Turncare, Inc
- Inspection Date: 2023-06-26
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Turncare, Inc. in Pompton Plains, NJ, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and control of nonconforming products. Additionally, issues were noted with equipment calibration, employee training, management review, quality audits, device history records, and document approval, indicating a pervasive lack of quality system control.

## Related Documents

- [483 - 2024-12-11](https://www.keypedia.com/records/483/turncare-inc/1c255d62-4160-47b3-9e51-ab15b3b60ec6)

## Related Officers

- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/turncare-inc/1df2c7e7-aa75-466c-a9c3-eab33580cdc5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248